MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM1200 VALVE SET; SET, I.V. FLUID TRANSFER

Catalog Number H938792

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

D4: lot # likely lot number: 60486689 (customer couldn't confirm the lot).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix valve set leaked.The port that connects to the empty bag, fully disconnected from the tubing resulting in leak of solution.This occurred under the hood during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured between august 10, 2023 ¿ august 11, 2023.The device was received for evaluation.A visual inspection was performed, and it was noted that only the valve set silicone tubing was received and no valve body or connector was sent for evaluation which suggested the silicone outlet tubing was detached from the valve body outlet port.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM1200 VALVE SET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18731218
• MDR Text Key: 335825593
• Report Number: 1416980-2024-00636
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477305
• UDI-Public: (01)00085412477305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938792
• Device Lot Number: 60486689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1